BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 5509974 · Received March 18, 2016

    Report

    Report Number
    2953769-2016-00023
    Event Type
    Injury
    Date Received
    March 18, 2016
    Date of Event
    February 19, 2016
    Report Date
    February 22, 2016
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K # K041584 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BKP SURGERY FOR OSTEOPOROSIS ON (B)(6) 2016. ON (B)(6) 2016 POST-OP, THE PATIENT COMPLAINED OF RIGHT BACK PAIN ALTHOUGH THERE WAS NO PROBLEM DURING THE SURGERY. IT WAS FOUND BY CT IMAGE THAT CEMENT WAS LEAKED AT FRONT, UPPER AND SEGMENTAL VEIN. CEMENT LEAKED INTO SEGMENTAL ARTERY AND SUPERIOR OF ANTERIOR VERTEBRAL BODY. THE PATIENT WAS ELDERLY SO CAUSAL RELATIONSHIP BETWEEN CEMENT LEAKAGE AND BACKACHE WAS REPORTED UNKNOWN. THE SURGEON COMMENTED THAT CEMENT MIGHT HAVE BEEN SOFT. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED. LEVELS IMPLANTED: TH12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166654 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR